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Trinity ELE Plus and Trinity ELE Plus Pro

by Carol Cole Company dba NuFACE

510(k) K201906

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201906 Date24 Feb 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NFO
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Trinity ELE Plus and Trinity ELE Plus Pro are transcutaneous electrical stimulators designed for aesthetic purposes. Classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes, these devices deliver controlled electrical impulses to target facial muscles, intended to improve muscle tone and skin appearance through non-invasive stimulation.

These devices are supplied as reusable medical equipment and are regulated under 21 CFR 882.5890. They are cleared for use in non-clinical settings, such as home or professional aesthetic treatments, and are intended for single-user application. The devices are not sterile and require proper storage to maintain functionality. No MRI safety information is specified in the provided data.

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